CompletedPhase 3NCT01966003

Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

The purpose of this research study is to compare the effectiveness and safety of ABP 215 against bevacizumab in men and women with advanced non-small cell lung cancer.

Checked against the public recordLast updated Oct 19, 2017 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations4
SponsorAmgen
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Amgen
Interventions being studied
Drug: Carboplatin; Drug: Paclitaxel; Drug: ABP 215; Drug: Bevacizumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Inclusion Criteria: * Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) * Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 Exclusion Criteria: * Small cell lung cancer (SCLC) or mixed SCLC and NSCLC * Central nervous system (CNS) metastases * Malignancy other than NSCLC * Palliative radiotherapy for bone lesions inside the thorax * Prior radiotherapy of bone marrow * Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) * Life expectancy \< 6 months * Woman of child-bearing potential who is pregnant or is breast feeding or who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment * Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment * Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products * Other inclusion/exclusion criteria may apply

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Research SiteBismarck, North Dakota
  • Research SiteFremantle, Western Australia
  • Research SiteVeliko Tarnovo, Veliko Tarnovo
  • Research SiteRousse

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 19, 2017. Always confirm current availability with the study team.

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